MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-01-16 for AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS 412010 manufactured by Convatec Dominican Republic Inc.
[177402371]
(b)(6). Based on the available information, this event is deemed to be a reportable malfunction. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[177402372]
It was reported "on application the dressing pad did not absorb exudates and formed gel as intended and the hydro fiber pad came out from the packing while removing the dressing. The dressing started swelling up with the exudate and hence had to be removed form the suture line. " no harm was reported; however, the patient? S clothing was soiled. Photographs depicting the reported complaint issue were provided by the complainant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9618003-2020-00377 |
| MDR Report Key | 9597421 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-01-16 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-01 |
| Date Added to Maude | 2020-01-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Manufacturer G1 | CONVATEC DOMINICAN REPUBLIC INC |
| Manufacturer Street | KM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA |
| Manufacturer City | SAN CRISTOBAL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS |
| Generic Name | DRESSING, WOUND, DRUG |
| Product Code | FRO |
| Date Received | 2020-01-16 |
| Model Number | 412010 |
| Catalog Number | 412010 |
| Lot Number | 9G02694 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC DOMINICAN REPUBLIC INC |
| Manufacturer Address | KM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA SAN CRISTOBAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-16 |